The issue is that the products, intended to be sterile, may contain micororganisms. The U.S. Food and Drug Administration (FDA) warns that
administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
The warning follows an FDA investigation of NuVision. During the inspection, FDA officials observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk. A report
was issued by FDA on July 16, 2014.
The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, bacterial endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions.
NuVision’s products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435. FDA advises that health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.
The FDA also issued several warnings for NuVision Pharmacy last year, The Schmidt Law Firm
notes. The agency received at least six adverse event reports from patients who experienced fever, flu-like symptoms, chills, and soreness after receiving injections of methylocobalamin.
Last week FDA warned health care professionals
, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may also be contaminated.